Dimia pills film coated 3 mg + 0.02 mg N28x3
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Active ingredients
Drospirenone + Ethinyl Estradiol
Release form
Pills
Composition
In 1 tablet: ethinyl estradiol 20 mcg; drospirenone 3 mg. Adjuvants: lactose monohydrate - 48.53 mg, corn starch - 16.6 mg, pregelatinized corn starch - 9.6 mg, macrogol and polyvinyl alcohol copolymer - 1.45 mg, magnesium stearate - 0.8 mg.
Pharmacological effect
Drug dimia; is a combination monophasic oral contraceptive containing drospirenone and ethinyl estradiol. In terms of its pharmacological profile, drospirenone is close to natural progesterone: it does not possess estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by pronounced anti-androgenic and moderate anti-mineralocorticoid action. The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secret and the change in the endometrium. The Pearl Index, an indicator reflecting the frequency of pregnancy in 100 women of reproductive age during a year of using a contraceptive, is less than 1.
Pharmacokinetics
Drospirenone Absorption: When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax of drospirenone in serum is about 38 ng / ml and is achieved approximately 1-2 hours after a single dose. Bioavailability is 76-85%. Simultaneous intake with food does not affect the bioavailability of drospirenone. Distribution: After ingestion, the concentration of drospirenone in the blood plasma decreased with the final T1 / 2 31 h. binding globulin (transcortin). Only 3-5% of the total serum concentration of drospirenone exists as free steroids. An ethinyl estradiol-induced increase in SHBG does not affect the binding of drospirenone to serum proteins. The mean apparent Vd of drospirenone is 3.7 ± 1.2 l / kg. During the treatment cycle, Cssmax of plasma drospirenone is about 70 ng / ml, it is reached after 8 days of treatment. Serum concentrations of drospirenone increase by about 3 times due to the ratio of the final T1 / 2 and the dosing interval. Metabolism: Drospirenone is actively metabolized after ingestion.The main metabolites in the blood plasma are the acid forms of drospirenone, formed during the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both formed without the participation of the P450 system. Drospirenone is metabolized to a small extent by CYP3A4 and is able to inhibit this enzyme, as well as CYP1A1, CYP2C9 and CYP2C19 in vitro. Excretion: The renal clearance of serum metabolites of drospirenone is 1.5 ± 0.2 ml / min / kg. Drospirenone is excreted only in trace amounts in unchanged form. Metabolites of drospirenone are excreted by the kidneys and through the intestine with an excretion ratio of about 1.2: 1.4. T1 / 2 metabolites by the kidneys and through the intestines is about 40 hours. Ethinyl estradiol Absorption: When taken orally, ethinyl estradiol is absorbed quickly and completely. Cmax in serum is about 33 pg / ml and is achieved within 1-2 hours after a single oral administration. Absolute bioavailability as a result of presystemic conjugation and presystemic metabolism is approximately 60%. Simultaneous food intake reduced the bioavailability of ethinyl estradiol in approximately 25% of the patients examined; other changes did not occur. Distribution: The serum concentrations of ethinyl estradiol decreased in two phases, in the final phase of the distribution T1 / 2 is approximately 24 hours. Ethinyl estradiol is well, but non-specifically associated with serum albumin (approximately 98.5%) and induces an increase in serum concentrations of HBHG. The apparent Vd is about 5 l / kg. Css is reached in the second half of the treatment cycle, and the serum concentration of ethinyl estradiol is increased by 2-2.3 times. Metabolism: Ethinyl estradiol is a substrate of presystemic conjugation in the mucous membrane of the small intestine and in the liver. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, forming a wide range of hydroxylated and methylated metabolites, which are present both in free form and in the form of conjugates with glucuronic acid. The renal clearance of ethinyl estradiol metabolites is approximately 5 ml / min / kg. Excretion: Unchanged ethinyl estradiol is practically not excreted. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestine at a ratio of 4: 6. T1 / 2 metabolites is about 24 hours. Pharmacokinetics in specificClinical cases In renal dysfunction: Css Drospirenone in the blood plasma of women with mild severity of renal failure (CC 50-80 ml / min) was comparable to the corresponding indicators in women with normal renal function (CC> 80 ml / min). In women with moderately severe renal failure (CC from 30 ml / min to 50 ml / min), plasma concentration of drospirenone was on average 37% higher than in women with normal renal function. Drospirenone was well tolerated in all groups. The intake of drospirenone did not have a clinically significant effect on the content of potassium in the blood serum. The pharmacokinetics of severe renal failure has not been studied. In case of impaired liver function: Drospirenone is well tolerated by patients with mild to moderate degrees of liver failure (grade B on the Child-Pugh scale). Pharmacokinetics for severe hepatic insufficiency has not been studied.
Indications
Oral contraception.
Contraindications
The drug Dimia; like other combined oral contraceptives, is contraindicated in any of the following: - thrombosis (arterial and venous) and thromboembolism at present or in history (including thrombosis, deep vein thrombophlebitis; pulmonary thromboembolism , myocardial infarction, stroke, cerebrovascular disorders); - conditions that precede thrombosis (including transient ischemic attacks, angina) at the present time or in history; - multiple or pronounced risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of cerebral vessels or coronary arteries; uncontrolled arterial hypertension, volumetric surgery with prolonged immobilization, smoking over 35 years old, obesity with a BMI> 30 kg / m2, - hereditary or acquired susceptibility to venous or arterial thrombosis, for example, resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antibodies against phospholipids (presence of antibodies to phospholipids - antibodies to cardiolipin, lupus anticoagulant); - pancreatitis with express hypertriglyceridemia constant current or history; - existing severe liver disease (or disorder) providedthat liver function is still not normalized; - severe chronic or acute renal failure; - liver tumor (benign or malignant) now or in history; - hormone-dependent malignant neoplasms of the genital or mammary gland at the present time or in history; - vaginal bleeding of unknown origin; - migraine with focal neurological symptoms in history; - lactase deficiency, lactose intolerance, glucose-galactose malabsorption, lactase deficiency la pp (lactase deficiency in some ethnic groups of the North); - pregnancy and suspicion of it; - lactation period; - hypersensitivity to the drug or to any of the components of the drug.
Precautionary measures
With caution; - risk factors for thrombosis and thromboembolism: smoking before the age of 35, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary susceptibility to thrombosis, thrombosis, I have not been able to do so with heart failure, I am using heart failure, I am using heart failure, I am using the heart rate function (I), I, I, I am using heart failure, I am using thrombosis (I), I, I, I, I am using thrombosis, I am not interested in thrombosis (I), Istrophic heart disease (IHG) at a young age in one of the closest relatives); - diseases in which there may be violations of the peripheral circulation: diabetes mellitus without convulsive complications, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins; - hereditary angioedema; - hypertriglyceridemia; - severe liver disease (until normal liver function tests) - Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with impairment of hearing, porphyria, g Herpes during pregnancy in history, small chorea (Sydenhem disease), chloasma); - postpartum period.
Use during pregnancy and lactation
Drug dimia; contraindicated in pregnancy. If the pregnancy occurred while using the drug Dimia ;, it should be stopped immediately. Extended epidemiological studies have not revealed an increase in the risk of birth defects in children born to womentaking the CCP before pregnancy, nor the teratogenic action of the CCP when they are unintentionally taken during pregnancy. According to preclinical studies, undesirable effects that affect the course of pregnancy and fetal development due to the hormonal action of the active components cannot be excluded. Drug dimia; can affect lactation: reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and / or their metabolites can be excreted with milk while taking CPC. These quantities may affect the child. Use of the drug Dimia; during breastfeeding is contraindicated.
Dosage and administration
Tablets should be taken daily, at about the same time, with a small amount of water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days at 1 tab./day. Taking the pills from the next pack begins after taking the last pill from the previous pack. Withdrawal bleeding usually starts 2-3 days after starting the placebo pills (last row) and does not necessarily end at the beginning of the next pack. How to start taking Dimia; If hormonal contraceptives have not been used in the last month, take Dimia; begin on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is possible to start taking it on the 2nd-5th day of the menstrual cycle, in this case it is necessary to use the barrier method of contraception during the first 7 days of taking the pills from the first package. Transfer from other combined contraceptives (combined oral contraceptives in the form of pills, vaginal ring or transdermal plaster ) Start taking the drug Dimia; should be the next day after taking the last inactive pill (for drugs containing 28 pills) or the next day after taking the last active pill from the previous package (possibly the next day after the usual 7-day break) for drugs containing 21 pills packaged. If a woman uses a vaginal ring or a transdermal patch, take Dimia; it is preferable to start on the day of their removal or - at the latest - on the day,when it is planned to introduce a new ring or replace a plaster. Transfer from contraceptives containing only progestogens (mini-pili, injections, implants), or from the intrauterine system (IUD), releasing progestogens. A woman can switch from taking mini-pili to taking the drug Dimia; on any day (from the implant or from the IUD on the day of their removal, from the injection forms of drugs - on the day when the next injection should have been given), but in all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. abortion in the first trimester of pregnancy; taking the drug Dimia; may be initiated by a doctor on the day of termination of the pregnancy. In this case, the woman does not need to take additional contraceptive measures. After delivery or abortion in the second trimester of pregnancy. A woman is recommended to start taking the drug at 21-28 days after birth (provided that she does not breastfeed) or abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception during the first 7 days after the start of the drug Dimia; With the resumption of sexual activity (before starting the drug Dimia;) pregnancy should be excluded. Acceptance of missed pills Pass the placebo pills from the last (4th) row of blister can be ignored. However, they should be discarded in order to avoid an unintended prolongation of the placebo phase. The instructions below apply only to missed pills containing active ingredients. If the delay in taking the pill is less than 12 hours, the contraceptive protection is not reduced. A woman should take the missed pill as soon as possible (as soon as she remembers), and the next pill should be taken at the usual time. If the delay is longer than 12 hours, the contraceptive protection can be reduced. In this case, one can be guided by two basic rules: 1. Taking pills should never be interrupted for more than 7 days; 2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, it takes 7 days to continuously take pills. According to this, the following recommendations can be given to women: Days 1-7 A woman should take a missed pill as soon as she remembers it, even if it means taking two pills at the same time .She should then take the pills at the usual time. In addition, a barrier method, such as a condom, should be used within the next 7 days. If in the previous 7 days there was sexual intercourse, you should consider the possibility of pregnancy. The more pills are missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy. Days 8-14 A woman should take the missed pill as soon as she remembers, even if it means taking two pills at the same time. She should then take the pills at the usual time. If during the 7 days preceding the first missed pill, the woman took the pills as expected, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception is needed (barrier - for example, a condom) for 7 days. Days 15-24 The reliability of the method inevitably decreases as the placebo pills approach. However, correction of the pill regimen may still help in preventing pregnancy. When performing one of the two schemes described below, and if in the previous 7 days before the pill was missed, the woman followed the regimen of the drug, the need for additional contraceptive measures will not arise. If this is not the case, she should follow the first of the two schemes and use additional precautions over the next 7 days. A woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. She should then take the pills at the usual time until the active pills have run out. 4 placebo pills from the last row should not be taken, you need to immediately start taking the pills from the next blister pack. Most likely, the withdrawal bleeding will not occur until the end of the second package, but there may be spotting or withdrawal bleeding on the days of taking the drug from the second package. A woman may also interrupt the intake of active pills from the started packaging. Instead, she should take placebo pills from the last row for 4 days, including the days of skipping pills,and then start taking the pills from the next package. If a woman missed taking the pills and subsequently did not experience withdrawal bleeding in the placebo pills phase, consider the possibility of pregnancy. Use of the drug for gastrointestinal disorders In case of severe gastrointestinal disorders (for example, vomiting or diarrhea) absorption of the drug will be incomplete, and additional contraceptive measures will be required. If vomiting has occurred within 3-4 hours after taking the active pill, it is necessary to take a new (replacement) pill as soon as possible. If possible, the next pill should be taken within 12 hours of the usual time taken to take the pills. If more than 12 hours have passed, it is recommended that you proceed as directed when skipping pills. If a woman does not want to change the usual regimen of pills, she should take an extra pill from another package. Delaying menstrual-like bleeding is canceled. To postpone bleeding, a woman should skip the placebo pills from the started package and start taking drospirenone + ethinyl estradiol from the new package. The delay can be prolonged until the active pills in the second package run out. During a delay, a woman may experience acyclic abundant or spotting bleeding from the vagina. Regular intake of the drug Dimia; It resumes after the placebo phase. To shift the bleeding on another day of the week, it is recommended to shorten the upcoming phase of taking placebo pills for the desired number of days. When shortening the cycle, it is more likely that the woman will not have menstrual-like withdrawal bleeding, but there will be acyclic abundant or spotting bleeding from the vagina when taking the next package (as well as when the cycle is lengthened).
Side effects
While taking the drug Dimia; The following adverse events were reported: Organ system class Frequent (≥1 / 100 to <1/10) Less frequent (≥1 / 1000 to <1/100) Rare (≥ 1/10 000 to <1/1000) Infections and candidiasis invasion including oral cavity From the side of blood and lymphatic system anemia, thrombocytopeniaOn the side of the immune system, allergic reactions From the side of metabolism and nutrition, an increase in body weight increased appetite, anorexia, hyperkalemia,hyponatremia, weight loss. On the psychic side, emotional lability, depression, decreased libido, nervousness, drowsiness, anorgasmia, insomnia. On the nervous system, headache, dizziness, vertigo paresthesia, tremor. On the part of the organ of vision, conjunctivitis, dry eye, impaired vision, heart, and heart. varicose veins, increased blood pressure tachycardia, phlebitis, vascular lesions, nosebleeds, fainting. On the digestive system, nausea, pain in life e vomiting, diarrhea. Liver and biliary tract. Gall bladder soreness, cholecystitis. From the side of skin and subcutaneous tissue rash (including acne), pruritus chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertricosis, skin lesions , skin striae, contact dermatitis, photodermatitis, skin nodules On the part of the musculoskeletal system, back pain, pain in the extremities, muscular cramps Reproductive system and breast pain, chest pain, absence of bleeding withdrawal vaginal candidiasis, pelvic b e, breast augmentation, breast fibrocystosis, vaginal discharge, flushing, vaginitis, acyclic bleeding, painful menstrual-like bleeding, heavy withdrawal bleeding, scanty menstrual-like bleeding, dry vaginal mucosa, altered cytology in a smear of a vaginal smear, a change in the cytological smear of a menstrual-like bleeding, dry vaginal mucosa, changes in the cytological pattern of the smear of the vagina, changes in the cytological pattern of the smear of the vagina, change the cytological pattern in the smear of the vagina, change the cytological pattern in the smear of the vagina, change the cytological pattern in the smear , vulvovaginitis, postcoital bleeding, breast cyst, breast hyperplasia, breast cancer, cervical polyps, atrophy, endometer I, ovarian cyst, increased matki.Obschie; asthenia disorders, increased sweating, edema (generalized edema), peripheral edema, swelling of the face) discomfort. Women who use combined oral contraceptives (PAC) have the following serious adverse events: - venous thromboembolic diseases; - arterial thromboembolic diseases; - tumors liver - the occurrence or exacerbation of conditions for which the connection with the admission of the CPC is not proven: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine myoma, porphyria, systemic dark lupus erythematosusherpes during a previous pregnancy, rheumatic chorea, hemolytic-uremic syndrome, cholestatic jaundice; - chloasma; - acute or chronic liver disease may necessitate discontinuation of CPC before normalization of functional liver function tests; - in women with hereditary angioedema, or exacerbate the symptoms of angioedema.
Overdose
Cases of drug overdose Dimia; not yet. Based on the general experience of using combined oral contraceptives, the potential symptoms of an overdose can be: nausea, vomiting, slight bleeding from the vagina. Treatment: there are no antidotes. Treatment should be symptomatic.
Interaction with other drugs
The effect of other drugs on the drug Dimia; Interactions between oral contraceptives and other drugs may cause acyclic bleeding and / or ineffective contraception. The following interactions are reflected in the scientific literature. The interaction mechanism with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and Hypericum perforatum preparations are based on the ability of these active substances to induce microsomal liver enzymes. Maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy. Contraception is also ineffective when taking antibiotics, for example, ampicillin and tetracycline. The mechanism of this phenomenon is not clear. Women with short-term treatment (up to one week) by any of the above groups of drugs or monopreparations should temporarily use (during the co-administration of other drugs and for another 7 days after its termination), in addition to the CPC, barrier methods contraception. Women receiving rifampicin therapy other than taking CPC should use a barrier method of contraception and continue to use it for 28 days after stopping rifampicin treatment.If the concomitant medication lasts longer than the active pills in the package, the inactive pills should be discontinued and the drospirenone + ethinyl estradiol pills should be taken immediately from the following package. The main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system. Inhibitors of cytochrome P450, therefore, are unlikely to affect the metabolism of drospirenone. The effect of the drug Dimia; other drugs Oral contraceptives can affect the metabolism of some other active ingredients. Accordingly, the concentrations of these substances in the blood plasma or tissues can either increase (for example, cyclosporine) or decrease (for example, lamotrigine). substrate, the effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely. Other interactions In patients without renal failure, the simultaneous use of drospirenone and ACE or NSAID inhibitors a significant effect on the potassium content in the blood serum. But still the simultaneous use of the drug Dimia; with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, the concentration of serum potassium should be monitored during the first cycle of treatment. binding proteins and lipid / lipoprotein fractions, parameters of carbohydrate metabolism and parameters of blood coagulation and fibrinolysis. In general, changes remain within the normal range. Drospirenone causes an increase in plasma renin activity and, due to a small anti-mineralocorticoid activity, decreases plasma aldosterone concentration.
special instructions
If there are any of the conditions / risk factors mentioned below, the benefits of taking PDA should be assessed individually for each woman and discussed with her before using. If an adverse event is exacerbated or if any of these conditions or risk factors appear, the woman should contact the doctor. The physician must decide whether to interrupt PDC intake. Circulatory disorders Violation of any combined oral contraceptive increases the risk of venous thromboembolism (VTE). The increase in the risk of VTE is most pronounced in the first year a woman uses a combined oral contraceptive. Epidemiological studies have shown that the incidence of VTE in women with no risk factors taking low doses of estrogen (<0.05 mg of ethinyl estradiol) in the composition of the combined oral contraceptive is approximately 20 cases per 100 000 women-years (for levonorgestrel-containing PDAs of the second generation) or 40 cases per 100,000 women-years (for deogestrel / gestodensis-containing PDAs of the third generation). For women who do not use the CCP, 5–10 VTE and 60 pregnancies per 100,000 women-years occur. VTE is fatal in 1-2% of cases. A large, prospective, 3-way study showed that the incidence of VTE in women with or without other risk factors for venous thromboembolism using a combination of ethinyl estradiol and drospirenone, 0.03 mg + 3 mg, coincides with the frequency VTE in women who have used levonorgestrel-containing oral contraceptives and other PDAs. The degree of risk of venous thromboembolism while taking the drug Dimia; currently not established. Epidemiological studies have also revealed a connection with taking CPC with an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders). It is rare for women taking oral contraceptives that thrombosis of other blood vessels, such as veins and hepatic arteries, kidney, brain, or retina. There is no consensus regarding the connection of these phenomena with hormonal contraceptives. Symptoms of venous or arterial thrombotic / thromboembolic phenomena or acute disorders of cerebral circulation: - unusual unilateral pain and / or swelling of the lower extremities; sudden severe chest pain,regardless of whether it gives to the left hand or not; sudden shortness of breath; sudden onset of cough; any unusual severe prolonged headache; sudden partial or complete loss of vision; diplopia; impaired speech or aphasia; vertigo; collapse with or without partial seizures; weakness or a very noticeable numbness that suddenly struck one side or one part of the body; movement disorders; symptom complex acute abdomen. Before starting a CPC, a woman should consult with a specialist. The risk of venous thromboembolic disorders when taking CPC increases with: an increase in age; hereditary predisposition (venous thromboembolism has ever happened to siblings or parents at a relatively early age); prolonged immobilization, extended surgery, any surgery on the lower limbs or a major injury. In such situations, it is recommended to stop taking the drug (in the case of a planned surgical intervention at least four weeks) and not to resume until two weeks after the full restoration of mobility. If the drug was not discontinued in advance, the possibility of anticoagulant treatment should be considered - obesity (BMI over 30 kg / m2); - there is no consensus about the possible role of varicose veins and surface thrombophlebitis with the appearance or exacerbation of venous thrombosis. violations of cerebral circulation when taking PDA increases with: increasing age; smoking (women over 35 are strongly advised to stop smoking if they want to take the CCP); dyslipoproteinemia; hypertension; migraine without focal neurological symptoms; obesity (BMI over 30 kg / m2); hereditary predisposition (arterial thromboembolism ever in siblings or parents at a relatively early age). If hereditary predisposition is possible, a woman should consult with a specialist before taking CPC; - heart valve damage; - atrial fibrillation. Having one serious risk factor for venous disease or several risk factors for arterial disease can also be a contraindication. The possibility of anticoagulant therapy should also be considered.Women taking PDA should be properly instructed to inform the attending physician in the event of a suspicion of thrombosis symptoms. If thrombosis is suspected or confirmed, the use of PDA should be stopped. Adequate alternative contraception should be initiated due to the teratogenicity of anticoagulant therapy (indirect anticoagulants derived from coumarin). Consider the increased risk of developing thromboembolism in the postpartum period. Other medical conditions associated with unwanted vascular events include diabetes, systemic red heart disease, a red-lance pattern, a red-dot pattern, and a red-dotted object, if there is a template, and a object has a target, and a object is applied to it. , chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia. An increase in the frequency or severity of migraine while taking CPC may be an indication for the immediate cancellation of combined oral contraceptives. Tumors The most significant risk factor for developing cervical cancer is infection with the human papilloma virus. Some epidemiological studies have reported an increased risk of developing cervical cancer with long-term use of combined oral contraceptives, but there are conflicting opinions about the extent to which these findings are related factors, such as cervical cancer testing or the use of barrier methods of contraception. A meta-analysis of the results of 54 epidemiological studies revealed a small